Cerebral Health and the FDA

Open Letter in Response to FDA Compliance Requests

March 1, 2010

In a recent letter dated January 7, 2010 issued by the Department of Health and Human Services of the Food and Drug Administration, officials claimed that Cerebral Health, LLC made "unapproved" claims in regards to several brain health products. Unfortunately, even unsolicited verbatim quotes by medical doctors (MDs), research scientists (PhDs), and testimonials from customers that included any mention of product efficacy in regards to medical conditions or diseases such as Alzheimer's disease and Attention Deficit Disorder were construed by FDA officials as making a "drug" claim that needed further clinical trials and approval to be authorized for public view or marketing. While we stand by our statements, it is imperative that Cerebral Health, LLC acquiesces to FDA requirements to continue serving our customers.

Cerebral Health, LLC responded immediately to FDA requests and promptly removed any mention of diseases or medical conditions from product literature that would make products "new drugs" under FDA guidelines. Cerebral Health, LLC is committed to cooperating with FDA officials on this matter and any others to maintain full compliance with FDA regulations that may effect business conduct in the United States. As an internationally oriented company, Cerebral Health, LLC seeks full compliance with regulating government agencies throughout the world. Cerebral Health, LLC shall be transparent upon such matters and respond promptly to any regulatory agency's requests for further disclosure or requirements to maintain full compliance.

As a company dedicated to providing premium quality brain health supplements, Cerebral Health, LLC is focused on the international OTC market. We hope to continue working with governments and regulatory agencies worldwide to better serve our international base. While Cerebral Health, LLC may pursue FDA approval and clinical trials to further substantiate product efficacy in regards to specific brain diseases and neurological conditions, we strongly encourage our current and prospective customers to carefully review the independent clinical studies that have already been conducted on all brain health ingredients in our products prior to use. Each of our products are carefully researched and formulated to be the most effective OTC supplements available on the market. An excellent website to conduct research on any ingredient in our products is PubMed provided by the National Institute of Health (NIH). See http://www.pubmed.gov

We look forward to exciting new developments in the neurosciences that will further refine our understanding of brain health and nutrition. Cerebral Health, LLC seeks to provide customers with the highest quality and most efficacious products in concert with recent research emanating from brain scientists around the world. We hope to continue this central mission well into the future.

Cordially,

Prof. Douglas J. Phillips II, Director of R&D

Supporting Documents:

Copy of FDA Letter to Cerebral Health, LLC dated 1.7.2010

Copy of Cerebral Health, LLC's response letter to FDA officials dated 1.16.2010